1. Field of the Invention
The present invention relates to respiratory interface devices for transporting a gas to and/or from an airway of a user and in particular to a faceplate including a customized contoured end to which a cushion may be coupled.
2. Description of the Related Art
A variety of respiratory interface devices are known in the art. These interface devices include a mask, or respiratory interface device, through which gases can be provided (e.g., at a positive pressure) for consumption by the user. Such masks include, without limitation, nasal/oral masks that fit over the mouth and nose of the user, nasal masks which fit over only the nose of the user, and nasal pillows with prongs which fit into the nares of the user. It is known to maintain such interfaces on the face of a user by a headgear that wraps around the head of the user. The uses for such interface devices include high altitude breathing (aviation applications), swimming, mining, fire fighting and various medical diagnostic and therapeutic applications.
One requisite of many of these interface devices, particularly medical respiratory interface devices, is that they provide an effective fit against the user's face to limit or prevent leakage of the gas being supplied. In an exemplary embodiment, masks include a rigid faceplate and a resilient, flexible cushion. The cushion is coupled to the faceplate. Thus, the rigid faceplate provides support and maintains the general shape of the cushion. The cushion is structured to contact the user's face.
With the exception of custom made interface devices, faceplates and cushions are mass produced and are therefore generic. That is, the faceplates and cushions are not generally customized for a specific user. Masks including such faceplates and cushions provide a generally continuous seal against the user's face. A customized mask, however, provides a more complete seal.
A customized mask is based on a user's facial contours. That is, a user has their face scanned, or otherwise modeled, to create a user's 3D surface profile. The user's 3D surface profile is used to design a custom mask structured to substantially match the contours of the user's face. The custom mask is then produced for that user. Such a custom mask is structured to better engage the contours of the user's face. A custom mask may include a unitary faceplate and cushion. That is, the faceplate and cushion are molded as a single piece. Such custom masks are expensive. Moreover, the cushion is subject to wear and tear. Thus, when the cushion deteriorates, a new custom mask must be created.
Some custom masks utilize a custom cushion. That is, the faceplate is generic, but a custom cushion is created for a user based on a user's 3D surface profile, e.g. a facial profile. A user may have multiple cushions created, thereby reducing cost, but custom cushions are still expensive. Further, the user's supply of custom cushions will eventually need to be replenished. This means that either the manufacturer will need to maintain the molds for each user, or, the user will need to have a new mold made each time their supply of cushions needs to be replenished.
Accordingly a need exists for a mask that provides the advantages of a custom respiratory interface device, but that is less expensive to produce or which utilizes generic cushions while still providing a custom configuration.